Senior Engineer II, Quality Design Assurance

Integra LifeSciences; Mansfield (MA); On-site; USD 94,000 - 130,000; Full time

Job summary

Integra LifeSciences is seeking a Senior Engineer II, Quality Design Assurance to lead design and development activities for medical devices. You will collaborate with R&D and external partners, perform risk analyses, apply statistical methods, and ensure compliance with design control requirements across the product life cycle.

The role emphasizes leadership, cross-functional communication, and execution of test plans, validation, and transfer to manufacturing, with a focus on ISO 14971,

Qualifications

• Bachelor’s degree in engineering; Electrical/Electronic preferred; others considered.
• 5 years of experience in a medical device or regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD, IEC 62366, ISO 13485, FDA QSR and cGMP.
• Strong analytical skills and working knowledge of problem-solving methodologies.
• Working knowledge of DFSS techniques, process improvement techniques, and Lean process improvement techniques.
• 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development.
• Knowledge of industry best practices in Risk Management, processes, tools and technology.

Responsibilities

• Lead and/or support the design and development of medical devices with R&D and external partners, including software requirements and architectures.
• Lead and/or support risk analysis activities (FMEAs and SHAs) with risk management tools and practices.
• Apply statistical methods and process/design excellence tools to establish test plans and evaluate data and processes.
• Demonstrate proficiency in DFSS, Lean and process improvement techniques.
• Proficiency in Design/Process Verification and Validation, GR&R, SPC and sampling plans.
• Develop test methods for equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities in development and base business.
• Contribute to root cause investigations and corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans.
• Provide leadership in the Quality System (CAPA, Risk, Complaints, Post-Market Surveillance, etc.).
• Fulfill design control requirements per FDA and ISO guidelines; manage documentation and reviews.
• Support Design and Technical Review; communicate across departments.
• Demonstrate project management and leadership capabilities; participate in audits.

Skills

Quality Assurance

Risk Management

Statistical Analysis

DFSS

Lean Process Improvement

GR&R

Statistical Sampling Plan

Statistical Process Control

Project Leadership

Communication Skills

Education

Bachelor’s degree in engineering (Electrical/Electronic preferred)

Tools

MS Office

Statistical Software

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Senior Engineer II, Quality Design Assurance , will work within the Integra Lifesciences CSS Quality organization to support the development of new Medical Devices. Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills. The position will support line extensions of existing products as part of the new product development process, as well as design related aspects of product and process transfers between manufacturing sites. This position will have responsibility for new product introduction and development to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must-have.

For this Sr II role, ideal candidate will be a Subject Matter Expert with ISO11607, 10993, and functional cascading system requirements to component drawings, balancing the use of Y14.5 with the needs of the business.

Primary responsibilities are to:

• Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
• Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
• Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
• Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
• Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities both in product development and base business
• Contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans
• Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
• Support Design and Technical Review
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
• Demonstrate project management and leadership abilities
• Participate to internal and external audits.
• Maintain the Quality System

Qualifications

• Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
• 5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
• Strong analytical skills and a working knowledge of problem-solving methodologies
• Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
• Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
• Demonstrates excellent organizational, verbal and written communication skills
• Proficient with the MS Office Suite, and statistical software.
• Must be able to work independently with minimal supervision.
• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives

Salary Pay Range:

$94,300.00 - $129,950.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].